AccessGUDID - DEVICE: Plus (B553PLUS120)

GUDID

Device Identifier (DI) Information

Brand Name: Plus
Version or Model: v1.2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: WELLDOC, INC.

Primary DI Number: B553PLUS120
Issuing Agency: HIBCC
Commercial Distribution End Date: January 03, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 021217115 *Terms of Use

Device Description: The Plus System is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. The Plus System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The Plus System analyzes and reports blood glucose test results and supports medication adherence. In addition, the Plus System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. The Plus System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61215	Home pharmaceutical management support software	A software package intended to be used by patients at home, and healthcare professionals in a clinical setting, to facilitate therapeutic pharmaceutical management decisions (e.g., dosage) by providing suggested regimes for individual patients based on their physical and laboratory data. It is intended to be used on a non-medical computerized device (e.g., to be used on mobile devices at point-of-care); it is not intended to support anaesthesia administration.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRZ	Accessories, Pump, Infusion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190013	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2b8c8ccc-42c8-4512-97be-67519b2dd193
Public Version Date: November 03, 2023
Public Version Number: 5
DI Record Publish Date: November 23, 2021